Baxano Inc. said Tuesday it has received CE Mark approval for its branded iO-Flex System for spinal decompression surgery into European markets. The approval means that its technology meets European health, safety and environmental standards.
The San Jose-based private medical device company's product has already received U.S. Food and Drug Administration clearance. It makes products that help to restore spine function, preserve healthy tissue and improve patient quality of life.
“This is a major milestone for the company,” said Tony Recupero, the president and CEO of Baxano in a prepared statement. “Although our immediate focus remains supporting our domestic sales demand, we look forward to working with our international surgeon partners and being able to provide their patients suffering from lumbar spinal stenosis a new minimally invasive surgical option.”